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Biological Researcher I

Date: Feb 6, 2019

Location: West Chester, Pennsylvania, US, 19382

Company: Teva Pharmaceuticals

Company Info

Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic and innovative drugs including biosimilars, bio-betters, and innovative biologics.  Teva has recently developed 2 innovative biologics through to US FDA approval: Cinqair for severe forms of asthma and Ajovy for the prevention of migraine.  The development of these products was led by Teva’s West Chester Specialty R&D Center in Pennsylvania.  This site has grown rapidly over the last 3 years and will reach over 600 employees by 2019.  The CMC Biologics group is comprised of 170 FTEs responsible for both Innovative and Biosimilars.  Teva is aggressively increasing their biologics activities to ensure that they will be well-positioned and plan to reach 3 INDs per year from internal R&D in the years to come.

Job Description

RESPONSIBILITIES:

  • Fully accountable for Operation of GLP Fill-Finish manufacturing facility for parenteral DPs
    • Equipment set up, qualification and maintenance
    • Establishing process flows and manufacturing records
    • Perform necessary process development evaluations
    • Interface with internal and external vendors to manage supplies and inventories

 

  • Perform all activities supporting the production of sterile DP, including but not limited to: operation of the filling line, filter integrity testing, preparation of components and supplies including use of the autoclave, documentation (batch records, logbooks, etc.), routine in-process analytical testing, visual inspection, and cleaning of critical process equipment.
  • Support supply chain logistics to enable early Toxicology and Clinical DP manufacturing including materials movement, change controls, relevant documentation readiness through interface with internal or external CMO sites.
  • Stay compliant with the company’s SOP and applicable regulations.
  • Assist with the development of batch records, test protocols, sampling plans.
  • Perform technical troubleshooting of the filling line and related systems.
  • Support operation of a non-GMP development Lab, toxicological study materials, and conducting other product development studies.

Qualifications

REQUIRED QUALIFICATIONS:

  • Education: B.S. in a related field with a minimum of 1-2 years or M.S with a minimum of 0-1 years of experience in pharmaceutical/biotech industry.
  • At least 1 year hands-on production experience in an aseptic processing environment/clean rooms.
  • Prior experience in related manufacturing technical services is a plus.
  • Experience with batch records, logbooks, and electronic data collection systems commonly used in production environment.
  • Experience operating and troubleshooting parenteral filling equipment.
  • Experience in visual inspection of parenteral products, buffer formulation & dilution.
  • Basic understanding of microbiology, HVAC, and as they relate to the manufacture of sterile drug products.
  • Excellent verbal and written communication skills; proficiency in good documentation practices essential.
  • Impeccable personal integrity and a commitment to transparency.

     

Function

Research & Development

Sub Function

Biological Research

Reports To

Scientist, Formulatoin & Product Development

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Philadelphia

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